Method and device for pressure offloading

ABSTRACT

The present invention is a method and device for pressure offloading in order to alleviate or diminish pressure on an area of bony prominence, a blemish, wound, decubitus ulcer (also known as pressure ulcer or pressure sore) or surgical site by elevating the affected area above a surface without directly contacting the affected area. An interior filling of the present invention is composed of a Visco/Memory foam, natural buckwheat hulls, whole buckwheat seeds, millet hulls, water, gel, silicone, Styrofoam beads, a combination thereof, or other suitable material known in the art. The interior filling is enclosed in a hollow member, and an additional removable and/or reusable cover composed of anti-bacterial/anti-microbial fabric, encloses the hollow member for additional protection. Fastening means are attached to the cover to allow the user to reconfigure the shape of the device to provide the required support as needed for each use.

CROSS-REFERENCE TO RELATED APPLICATIONS

We hereby claim benefit under Title 35, United States Code, Section 120of U.S. patent application Ser. No. 11/230108 filed on Sep. 19, 2005(hereinafter “Prior Application”). This application is aContinuation-in-Part of the Prior Application. The Prior Application iscurrently pending. The Prior Application is hereby incorporated in itsentirety by reference into this application.

FIELD OF THE INVENTION

This invention relates generally to the treatment, healing andprevention of wounds, and more particularly' to a method and device foralleviating or diminishing pressure on a bony prominence, wound,blemish, decubitus ulcer (also known as pressure ulcer or pressure sore)or surgical site.

BACKGROUND OF THE INVENTION

Chronic wounds are a great burden to healthcare and account for billionsof dollars in healthcare costs annually.

Pressure sores are a localized area of damaged tissue. Pressure soresoccur when soft tissue between a bony prominence and an external surfaceis compressed for an extended amount of time. Pressure sores, also knownas bed sores or decubitus ulcers usually occur from confinement to abed, chair or wheelchair. In many instances, pressure sores are asecondary result of another illness or condition that leaves a personimmobile.

Patients who are immobile tend to lie in one position for hours on end.This causes a decrease in blood circulation to certain pressure pointson the body known as “bony prominences”, such as, for example, ears,shoulders, hips, coccyx (tail bone), buttocks, elbows, ankles and heels,to name a few. These areas are typically the first to break down. Thetissue closest to the bone is the most susceptible to pressure sores soa visible skin discoloration may indicate the beginning stages of apressure sore. The tissue begins to decay from lack of bloodcirculation. This is the basic formation of decubitus ulcer development.Thus, a lesion or a pressure sore may develop on skin and underlyingtissue due to unrelieved pressure over a bony prominence.

The prevalence of pressure sores in the United States alone is estimatedto be between 1.5 to 3.0 million people. Every year an estimated 60,000people die from a IS bedsore complication. An aging population, anincrease in diabetes and a nursing shortage have also contributed to anincrease in pressure ulcers.

Pressure sores will appear as a red area that can develop into an openwound if left without medical treatment. If pressure sores are leftuntreated, they can lead to severe health complications and even death.

A decubitus ulcer or pressure sore can range from a very mild pinkcoloration of the skin, which disappears in a few hours after pressureis relieved on the area, to a very deep wound extending to and sometimesthrough a bone into an internal organ. These ulcers, as well as otherwound types, are classified in stages according to the severity of thewound.

The usual mechanism of forming a decubitus ulcer is from pressure.However, it can also occur from friction, such as by rubbing against abed sheet, cast, brace, or the like.

The pressure sore and the affected area must be kept clean and clear ofany dead tissue. Because pressure sores can expose a patient toinfection entering the blood stream, a potentially deadly conditioncalled sepsis, medical care is a very necessary and worthwhileprecaution. It has been reported in fact, that sepsis is the 11^(th)leading cause of death, overall.

The goal in the treatment, healing and prevention of pressure sores isto relieve the pressure on and around bony prominences. This can beaccomplished by increasing air flow and blood flow to the affected areaso that pressure sores do not continue to worsen.

Thus, pressure management is a critical part of a successful treatmentprogram. Redistributing pressure away from a wound or an area of bonyprominence aids in the treatment and prevention of pressure ulcers.

Support devices can help relieve some of the pressure on the pressuresores. Wound care products comprise devices for open wound support, suchas medicated dressings, wraps, protectors, mattress pads and cushions.

Although these devices and treatments are helpful, they remainineffective in many respects. Dressings and wraps, for example, are indirect physical contact with the wound surface. Consequently, thesedevices apply pressure on the wound area. This pressure results in alonger healing time and the affected areas are therefore more prone tothe formation of decubitus ulcers.

Mattress pads and cushions also have considerable drawbacks. Themattress pads and cushions available today have a definite geometricalshape and size which cannot be easily altered to adapt to individualneeds.

Wound protectors are typically used during the transportation ofaccident victims. These protectors often cannot be applied to bed soresor some surgical sites because of their limited design.

Thus, there is clear and distinct need for a device which willeffectively alleviate or diminish pressure on a wound while alsoavoiding direct physical contact with the wound, blemish, pressure ulceror surgical site.

It is known in the art to use a cushioning means for the purpose ofelevating the body and increasing air flow to pressure points, therebyreducing the incidence of pressure or decubitus ulcers.

For example, U.S. Pat. No. 5,511,260 (to Dinsmoor III et al.) and U.S.Pat. No. 4,614,000 (to Mayer), U.S. Pat. No. 4,959,059 (to Eilender),U.S. Pat. No. 4,962,769 (to Garcia), U.S. Pat. No. 5,462,519 (to Carver)and U.S. Pat. No. 4,425,676 (to Crane), teach a mattress replacement ortreatment overlay for the purpose of elevating the body and increasingair flow to certain pressure points, thereby reducing the incidence ofpressure or decubitus ulcers.

These cushioning means, however, are large and bulky and cannot beeasily manipulated to alter their shape or size to accommodateindividual needs.

U.S. Pat. No. 4,779,297 (to Sturges), teaches a compact cushion supportarticle for the purpose of elevating the body, increasing air flow topressure points, and thereby reducing the incidence of pressure ordecubitus ulcers.

These devices however, are of limited use, since their shape and sizecannot be altered and manipulated with ease. A device with a definedgeometric shape, for example, a donut, can not be converted to adoptalternate shapes, for example, a linear, S-shape or U-shape. Hence itsusefulness is limited.

Similarly, the “Waffle Extended Care Cushion” from EHOB, Inc., althoughcompact, cannot be manipulated with ease to adopt a different shape orsize.

U.S. Patent Application No. 20030163072 (to Cristian Hueso) teaches aconic arch device that provides physical protection to any superficialwound. However, as with the “donut” and “waffle” shaped cushions, theshape of this device is not capable of being easily altered and cannotbe adapted to accommodate individual needs.

U.S. Pat. No. 6,009,577 (to Day), U.S. Pat. No. 5,638,564 (toGreenwalt), U.S. Pat. No. 5,615,432 (to Van Ohlen III) and U.S. Pat. No.6,595,935 (to Gerstmar) teach that it is known in the art to have acrescent or U-shaped type pillow as a cushioning means for the head andneck. These devices, however have not been adapted for the treatment orprevention of pressure sores, decubitus ulcers, etc.

Thus, there is a definite, distinct, and even urgent need for a devicein the treatment of decubitus ulcers, wounds, blemishes, etc. which willredistribute and alleviate pressure from a wound or area of bonyprominence, without covering the wound, blemish, pressure ulcer orsurgical site and which is capable of easily being manipulated toconform to individualized needs.

The present invention accomplishes these objectives and substantiallydeparts from the conventional concepts and designs of the prior art.

SUMMARY OF THE INVENTION

The present invention solves the foregoing problems by providing amethod and device for the treatment and prevention of wounds.

In view of the foregoing disadvantages in the treatment of wound care,the present invention discloses a method and device for offloadingpressure by elevating an area of bony prominence or a wound site,without covering the bony prominence or the wound. Thus byredistributing and off-loading pressure, pressure to the bony prominenceor wound site is alleviated. The affected area is elevated by the deviceand method of the present invention, while avoiding direct contact withthe wound or covering the wound, bony prominence, pressure ulcer orsurgical site.

Eliminating pressure while also avoiding covering the wound, allowsincreased air flow and blood circulation to the critical areas whichalleviates and ideally prevents the occurrence of decubitus ulcers.

The present invention comprises a material that conforms to a body'sshape and provides a custom molding or shaping type effect, such as, forexample, visco/memory foam, buckwheat hulls, millet hulls, water, gel,silicone, and the like, enclosed in a protective sheath. An additionalremovable cover may be placed over the protective sheath and can bewashed, sterilized and re-used.

A feature of the present invention is the use of tie strips,hook-and-loop fastener (“Velcro”) strips or other fastening means knownin the art. The tie strips, Velcro strips or other fastening means areattached to the external cover to adjust the shape of the device inorder to accommodate individualized and specific needs.

An object of the present invention is to provide a device foralleviating pressure from surface wounds which overcomes theshortcomings of the prior art in wound treatment.

An advantage of the present invention is that it provides a method toredistribute or offload pressure from a wound to allow increased airflow and blood circulation to aid in the treatment and prevention ofwounds and pressure sores.

An object of the present invention is to keep critical pressure pointsabove a surface, such as bedding.

An advantage of the disclosed invention is that it is proactive in theprevention of pressure ulcers and not merely reactive.

An object of the present invention is to provide a convenient,adjustable, malleable, portable, transportable and easy to use deviceand method in the treatment and prevention of wound care. The device ofthe present invention may be manipulated with greater ease andfrequency, in order to prevent injury and promote healing.

Another object of the method of the present invention is to surround acritical area such as a wound or bony prominence without covering thecritical area.

Another object of the present invention is to elevate an affected areaabove a surface, thereby eliminating direct contact between the woundand the surface, diminishing pressure on the wound

Another object of the present invention is to alleviate pressure fromsurface wounds with a device whose geometric shape and size can bealtered with ease in order to accommodate different wound sites.

Another object of the present invention is to diminish pressure fromsurface wounds with a device that is light weight and easy to handle.

Other objects and advantages of the present invention will becomeobvious to the reader and it is intended that these objects andadvantages are within the scope of the invention.

It is noted that the term wound as used throughout this application,includes but is not limited to, wounds from injuries, lesions, gashes,sores, abrasions and the like. Further, the terms wound, blemish,decubitus ulcer, pressure ulcer, pressure sore and surgical site areused interchangeably throughout this application.

There has thus been outlined, rather broadly, the more importantfeatures of the invention in order that the detailed description thereofmay be better understood, and in order that the present contribution tothe art may be better appreciated. Other features and advantages of thepresent invention will become apparent from the following more detaileddescription, taken in conjunction with the accompanying drawings, whichillustrate, by way of example, the principles of the invention.

DESCRIPTION OF THE DRAWINGS

FIG. 1A is a perspective view of an embodiment of the invention having agenerally circular cross section cushion, the cushion shown partiallyremoved from a protective hollow member 8;

FIG. 1B is a perspective view of an embodiment of the invention having agenerally square cross section cushion, the cushion shown partiallyremoved from the protective hollow member 8;

FIG. 2A is a cross-sectional view of the invention, taken generallyalong lines 2A-2A of FIG. 1A;

FIG. 2B is a cross-sectional view of the invention, taken generallyalong lines 2B-2B of FIG. 1B;

FIG. 3 is a perspective view of the embodiment of the invention having acircular cross shape cushion manipulated so as to form a U-shape;

FIG. 4 is a perspective view of the embodiment of the invention having asquare cross shape cushion manipulated so as to form an L-shape, toillustrate that the invention may be manipulated to form a variety ofdifferent shapes;

FIG. 5 is a perspective view of an embodiment of the present inventionhaving an inner longitudinal core, and illustrated without theprotective hollow member 8;

FIG. 6 is a perspective view of another embodiment of the presentinvention comprising three layers of filling material, such as twooutside layers of memory foam and an inner layer of polyethylene orpolyurethane, and illustrated without the protective hollow member 8;

FIG. 7 is a perspective view of an alternate embodiment of the presentinvention, partially cut away to reveal foam within the hollow member,particularly adapted for foot, illustrated in phantom outline, while inthe standing position;

FIG. 8 is a side elevation view of a patient laying on the device, and abed sore area of the patient elevated above and not touching the bedsurface;

FIG. 9 is a perpective view of a patient laying on the device, and a bedsore area of the patient elevated above and not touching the bedsurface;

FIG. 10 is a perspective view of the device surrounding and not coveringan area of bony prominence, such as a coccyx, showing the coccyxelevated above and not touching the bed surface;

FIG. 11 is a perspective view of a patient laying on the device, withareas of bony prominence, such as heels and ankles, elevated above andnot touching the bed surface; and

FIG. 12 is a perspective view of a patient laying her head on thedevice, with an area of bony prominence, such as an ear, elevated aboveand not touching the bed surface.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring to FIGS. 1A-1B, a device for alleviating or diminishingpressure from wounds according to an embodiment of the present inventionis identified generally at reference number 1.

A filling material is encased in a hollow member 8. The filling materialshown in FIGS. 1A-1B is a foam 16. Alternatively, the filling materialmay include for example, buckwheat hulls, millet hulls, water, gel,silicone or other material that conforms to a body's shape and providesa custom molding or shaping type effect.

The foam 16 is rolled in the general form of a circle as in FIG. 1A.Alternatively, the foam may be shaped to form a square, as in FIG. 1B,triangle (not shown), or any other suitable cross-section shape. An acidfree multi purpose spray adhesive, such as ELMER'S Craft Bond (notshown), or other adhesive material commonly known in the art, is used tomaintain the shape of the foam 16. The adhesive is applied to the foam16 prior to shaping the foam 16. Once the foam 16 is molded to thedesired shape, it is allowed to set for a suitable duration of time toallow the adhesive to cure. Alternatively, a slab of foam 16 of thedesired thickness may be cut to the desired cross-sectional shape, suchas for example, a circle or square, by any suitable means known in theart.

The hollow member 8 is preferably composed of a plastic film or othersuitable material and forms an overlay that acts as a protectivebarrier. As normally used, the hollow member 8 fully encloses thefilling material, but may include either an open end (as illustrated) ora longitudinal opening, such opening closable by a closure means such asa zipper, or the like (not shown). As noted, the filling material may beof varying cross-section shapes and lengths. The hollow member 8 ispreferably covered with a removable protective sheath or casing 2composed of anti-bacterial/anti-microbial fabric as is known in the art,to protect the hollow member 8 and keep the hollow member 8 from gettingsoiled.

Tie strips, such as for example, VELCRO strips, identified generally atreference number 5, or other suitable fastening means known in the artare attached to the removable protective sheath 2. The strips 5 are usedto adjust the geometrical shape and size of the device 1 as shown inFIG. 3.

FIGS. 2A and 2B show cross-sectional views across longitudinal axes of acircular cross-section shape of foam 16 and a square cross-section shapeof foam 16, respectively. An alternate filling material such as forexample, air, styrofoam beads, water, gel, silicone, buckwheat hulls,whole buckwheat seeds, millet hulls or any combination thereof may alsobe used in place of the foam 16, with the density and composition of thefilling variable to accommodate specific needs and body parts.

FIG. 3 shows a perspective view of the embodiment of the inventioncomposed of foam 16 with the circular cross-section cushion illustratedin FIG. 1A and manipulated to form a U-shape, the U-shape held in placeby fastening means such as tie strips 5.

FIG. 4 shows a perspective view of the embodiment of the inventionhaving foam 16 with the square cross-section cushion illustrated in FIG.1B and manipulated to form an L-shape, the L-shape held in place by afastening means, such as tie strips 5.

FIG. 5 is a perspective view of an embodiment of the present inventionin which a flexible rod 6 is provided in an aperture 7 in the device 1.The rod 6 may be comprised of a flexible plastic or other suitablematerial. As shown in FIG. 5, in this embodiment the device 1 has acircular cross-section comprised of foam 16. The rod 6 provides a solidsupport and is composed of a flexible plastic or other suitable materialsuch that it bends freely when the device 1 is manipulated to formvarious shapes to accommodate a patient 3.

FIG. 6 is a perspective view of another embodiment of the presentinvention comprising three distinct layers of filling material. Asshown, the device 1 is comprised of a top 16 a, bottom 16 b, and middle16 c layer. The top 16 a and bottom 16 b layers are preferably comprisedof foam 16, and the middle layer 16 c is preferably comprised ofpolyethylene, polyurethane or other suitable material and provides aflexible inner support.

FIG. 7 shows a perspective view of an alternate embodiment of thepresent invention particularly adapted to elevate the bony prominencesin a foot (shown in phantom outline), namely a heel 3 b and a ball 3 fof a foot. In this embodiment the hollow member 8 includes a top surface20 and a bottom surface 21. The filling material, such as the foam 16,assumes the shape of the hollow member 8 in this embodiment, or,alternately, the foam 16 and hollow member 8 are integrally formed. Thehollow member 8 includes a first hollow region 14 a for the ball 3 f ofthe foot and a second hollow region 14 b for the heel 3 b of the foot,thereby forming generally a figure-8 shape. Tie strips 5 or otherfastening means are used to secure the device 1 to the foot, with theball 3 f of the foot being over the first hollow region 14 a, and theheel 3 b of the foot being held over the second hollow region 14 b, suchthat the ball 3 f and heel 3 b of the foot are not in contact with thetop surface 20. As such, this embodiment supports the foot adjacent tobut not in direct contact with the ball 3 f and the heel 3 b of thefoot.

FIGS. 8-12 show a patient 3 as utilizing the present invention. Thedevice 1 is placed between the patient 3 and the surface 9 in order toelevate a portion of the patient 3 above the surface 9.

The pressure offloading device 1 is manipulated as in FIG. 8, to restbetween the patients' lower extremities 15 thereby elevating at leastfour areas of “bony prominence”; both ankle 3 b and heel 3 c regions,above the surface 9.

In FIGS. 9-12, the device 1 is manipulated to rest between the patient 3and the surface 9 in order to elevate the coccyx 3 a, heels 3 b, ankles3 c, a hip 3 d or an ear 3 e.

The device 1 may be adjusted and manipulated to take varying shapes byusing the tie strips 5 or other fastening means known in the art.

The cross sectional shape of the foam 16 may be of varying shapes andsizes. For example, the foam 16 may have a circular cross section asshown in FIG. 1A or a square cross section as shown in FIG. 1B, as wellas other suitable shapes and sizes not herein indicated but known in theart. The filling material provides the support required to elevate thebody, such that the wound is not in direct contact with a surface 9,such as bedding material or the like.

An alternate filling material, such as buckwheat hulls, gel, water,silicone and the like may be used (not shown). The said alternatefilling material may vary in cross shape and size.

The device 1 as described herein is designed to elevate a wound or oneor more areas prone to developing a wound, such as the coccyx 3 a, ankleand heel regions 3 b, 3 c above a surface 9, such as bedding, so thatthe surface 9 and the wound or target area is exposed. As a result ofincreased air flow and blood circulation, the wound heals faster andideally no pressure sores develop. The ability to tailor the device 1 tosuit individual needs allows a caregiver or the patient to manipulatethe shape of the device 1 for optimal use.

While various embodiments of the present invention have been describedabove, it should be understood that they have been presented by way ofexample only, and not limitation. It will be understood by those skilledin the art that various changes in form and details may be made thereinwithout departing from the spirit and scope of the invention. Thus, thebreadth and scope of the invention should not be limited by any of theabove-described exemplary embodiments.

1. A pressure offloading device for elevating at least one portion of apatient above a surface, the pressure offloading device comprising: (a)an elongated, flexible hollow member having first and second oppositeends, a longitudinal axis being defined there between; (b) fillingmaterial contained within and substantially filling the hollow member;and (c) fastening means disposed along an outer side of the hollowmember; whereby with the hollow member formed into a desired shape andfastening means selected and fastened together to maintain the hollowmember in the desired shape, the hollow member may be placed between thepatient and the surface such that at least a portion of the patient iselevated above the surface, the hollow member supporting the patientadjacent to but not in direct contact with said portion of the patient.2. The pressure offloading device of claim 1 wherein the hollow memberis comprised of a fabric material.
 3. The pressure offloading device ofclaim 1 wherein the hollow member is comprised of a water imperviouselastomeric material.
 4. The pressure offloading device of claim 1wherein the hollow member further includes closure means disposed alongone side thereof for providing access inside the hollow member.
 5. Thepressure offloading device of claim 1 wherein the hollow member has agenerally rectangular cross-section across the longitudinal axisthereof.
 6. The pressure offloading device of claim 1 wherein the hollowmember has a generally circular cross-section across the longitudinalaxis thereof.
 7. The pressure offloading device of claim 1 wherein thefilling material comprises a viscoelastic polyurethane foam.
 8. Thepressure offloading device of claim 1 wherein the filling materialcomprises buckwheat hulls.
 9. The pressure offloading device of claim 1wherein the filling material comprises silicone.
 10. The pressureoffloading device of claim 1 wherein the filling material comprises agelatinous material.
 11. The pressure offloading device of claim 1wherein the filling material comprises water.
 12. The pressureoffloading device of claim 1 wherein the filling material comprises anupper layer of viscoelastic polyurethane foam, a lower layer ofviscoelastic polyurethane foam, and at least one flexible inner supportpositioned between said upper and lower layers.
 13. The pressureoffloading device of claim 12 wherein said flexible inner supportcomprises a polyurethane material.
 14. The pressure offloading device ofclaim 12 wherein said flexible inner support comprises a polyethylenematerial.
 15. The pressure offloading device of claim 1 wherein aflexible rod is enclosed within said filling material.
 16. A pressureoffloading device for elevating at least one portion of a patient abovea surface, the pressure offloading device comprising: (a) an elongated,flexible hollow member having first and second opposite ends, alongitudinal axis being defined there between; (b) filling materialcontained within and substantially filling the hollow member; and (c) aflexible, removable cover adapted to snuggly fit over the hollow member,the removable cover having first and second opposite ends, alongitudinal axis being defined therebetween, and fastening meansdisposed along an outer side thereof, whereby with the removable coverencompassing the hollow member, the hollow member formed into a desiredshape, and fastening means selected and fastened together to maintainthe hollow member in the desired shape, the hollow member may be placedbetween the patient and the surface such that at least a portion of thepatient is elevated above the surface, the hollow member and coversupporting the patient adjacent to but not in direct contact with saidportion of the patient.
 17. The pressure offloading device of claim 16wherein the removable cover is made of an anti-bacterial andanti-microbial fabric.
 18. The pressure offloading device of claim 16wherein the removable cover further includes closure means disposedalong a side thereof for providing access inside the removable cover.19. The pressure offloading device of claim 16 wherein the hollow memberis comprised of a water impervious elastomeric material.
 20. Thepressure offloading device of claim 16 wherein the hollow member and theremovable cover each have a generally rectangular cross-section acrossthe longitudinal axis thereof.
 21. The pressure offloading device ofclaim 16 wherein the hollow member and the removable cover each have agenerally circular cross-section across the longitudinal axis thereof.22. The pressure offloading device of claim 16 wherein the fillingmaterial comprises a viscoelastic polyurethane foam.
 23. The pressureoffloading device of claim 16 wherein the filling material comprisesbuckwheat hulls.
 24. The pressure offloading device of claim 16 whereinthe filling material comprises silicone.
 25. The pressure offloadingdevice of claim 16 wherein the filling material comprises a gelatinousmaterial.
 26. The pressure offloading device of claim 16 wherein thefilling material comprises water.
 27. The pressure offloading device ofclaim 16 wherein the filling material comprises an upper layer ofviscoelastic polyurethane foam, a lower layer of viscoelasticpolyurethane foam, and at least one flexible inner support positionedbetween said upper and lower layers.
 28. The pressure offloading deviceof claim 27 wherein said flexible inner support comprises a polyurethanematerial.
 29. The pressure offloading device of claim 27 wherein saidflexible inner support comprises a polyethylene material.
 30. Thepressure offloading device of claim 16 wherein a flexible rod isenclosed with said filling material.
 31. A pressure offloading devicefor elevating a ball and a heel of a patient's foot above a surface, thepressure offloading device comprising: (a) an elongated, flexible hollowmember having an outer side that includes at least a top surface and abottom surface, a first hollow region and a second hollow region eachtraversing the hollow member from the top surface to the bottom surface,the hollow member forming substantially a figure-8 shape; (b) fillingmaterial contained within and substantially filling the hollow member;and (c) fastening means disposed along the outer side of the hollowmember; whereby with the patient's foot fastened to the top surface withthe fastening means, the ball of the foot being over the first hollowregion and the heel of the foot being over the second hollow region, theball and heel of the patient's foot are elevated above the surface, thehollow member supporting the foot adjacent to but not in direct contactwith the ball and the heel of the foot.
 32. A method of elevating atleast one portion of a patient above a surface, comprising the steps of:(a) providing a pressure offloading device comprising an elongated,flexible hollow member having first and second opposite ends, alongitudinal axis being defined there between; filling materialcontained within and substantially filling the hollow member; andfastening means disposed along an outer side of the hollow member; (b)forming the hollow member into a desired shape (c) selecting fasteningmeans and fastening same together to maintain the hollow member in thedesired shape; and (d) placing the hollow member between the patient andthe surface such that at least a portion of the patient is elevatedabove the surface, the hollow member supporting the patient adjacent tobut not in direct contact with said portion of the patient.
 33. Themethod of claim 32 wherein the portion of the patient that is elevatedis the patient's coccyx.
 34. The method of claim 32 wherein the portionof the patient that is elevated is at least one of the patient's heels.35. The method of claim 22 wherein the portion of the patient that iselevated is at least one of the patient's ankles.
 36. The method ofclaim 32 wherein the portion of the patient that is elevated is at leastone of the patient's hips.
 37. The method of claim 32 wherein theportion of the patient that is elevated is at least one of the patient'sears.
 38. A method of elevating a ball and a heel of a patient's footabove a surface, comprising the steps of: (a) providing an elongated,flexible hollow member having an outer side that includes at least a topsurface and a bottom surface, a first hollow region and a second hollowregion each traversing the hollow member from the top surface to thebottom surface, the hollow member forming substantially a figure-8shape; filling material contained within and substantially filling thehollow member; and fastening means disposed along the outer side of thehollow member (b) placing the ball of the patient's foot over the firsthollow region on the top surface of the hollow member, and the heel ofthe patient's foot over the second hollow region on the top surface ofthe hollow member; and (c) fastening the foot to the hollow member withthe fastening means.